Survivorship of Attune Primary Total Knee Prosthesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by DePuy International
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01754363
First received: December 18, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.


Condition Intervention
Noninflammatory Degenerative Joint Disease
Device: Attune Primary Total Knee Replacement

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Survivorship of each configuration. [ Time Frame: Minimum 15 years (5414 - 5658 days) ] [ Designated as safety issue: Yes ]
    Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).


Secondary Outcome Measures:
  • Survivorship [ Time Frame: Minimum 5 years (1764 - 3588 days) ] [ Designated as safety issue: Yes ]
    Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).

  • Survivorship [ Time Frame: Minimum 10 years (3589 - 5413 days) ] [ Designated as safety issue: Yes ]
    Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).

  • Implant fixation: Radiographic assessment of bone-implant interface performance [ Time Frame: Minimum 1 year (304 - 668 days) ] [ Designated as safety issue: No ]
    Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.

  • Implant fixation: Radiographic assessment of bone-implant interface performance [ Time Frame: Minimum 2 years (669 - 1763 days) ] [ Designated as safety issue: No ]
    Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.

  • Implant fixation: Radiographic assessment of bone-implant interface performance [ Time Frame: Minimum 5 years (1764 - 3588 days) ] [ Designated as safety issue: No ]
    Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.

  • Implant fixation: Radiographic assessment of bone-implant interface performance [ Time Frame: Minimum 10 years (3589 - 5413 days) ] [ Designated as safety issue: No ]
    Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.

  • Implant fixation: Radiographic assessment of bone-implant interface performance [ Time Frame: Minimum 15 years (5414 - 5658 days) ] [ Designated as safety issue: No ]
    Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.

  • Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L) [ Time Frame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days). ] [ Designated as safety issue: No ]
    EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.

  • Patient-reported Outcome: Oxford Knee Score [ Time Frame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days). ] [ Designated as safety issue: No ]
    The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likert-lie response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.

  • Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days). ] [ Designated as safety issue: No ]
    The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and includes the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales; pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert- like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  • Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP) [ Time Frame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days). ] [ Designated as safety issue: No ]
    The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.

  • Patient-reported Outcome: Knee Society Score [ Time Frame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days). ] [ Designated as safety issue: No ]
    The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). Likert responses are used, typically with five response options.

  • Evaluate the impact of surgeon learning curve on clinical and functional outcomes [ Time Frame: <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days). ] [ Designated as safety issue: No ]
    A surgeon learning curve will be investigated by comparing learning curve cases (the pooled cohort of each surgeon's first 10 study Subjects) with all investigational Subjects. All primary and secondary outcomes will be compared across the learning curve and post-learning curve Subject cohorts.

  • Evaluate changes in femoral component and tibial component alignment [ Time Frame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days). ] [ Designated as safety issue: No ]
    Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time.

  • Type and Frequency of Adverse Events (AEs) for all enrolled subjects [ Time Frame: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days). ] [ Designated as safety issue: Yes ]
    All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.


Estimated Enrollment: 1200
Study Start Date: February 2013
Estimated Study Completion Date: February 2030
Estimated Primary Completion Date: February 2030 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attune Primary Total Knee Replacement

Subjects will receive one of the following Attune total knee implants:

Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)

Device: Attune Primary Total Knee Replacement
Patients will undergo a primary total knee replacement using one of the four configurations of the Attune knee (CR FB, CR RP, PS FB, PS RP).

Detailed Description:

This study is designed as a prospective, single arm stratified, multi-centre investigation.

Approximately 30 sites, worldwide, will recruit 1200 patients (1200 knees). Each study site is expected to enroll approximately 50 patients (50 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There is no control group. One thousand two hundred (1200) Subjects will be stratified into 4 subgroups of 300: cruciate retaining fixed bearing(CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP).

Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

  Eligibility

Ages Eligible for Study:   22 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or female and between the ages of 22 and 75 years at the time of surgery, inclusive.
  • Subject was diagnosed with NIDJD.
  • Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae.
  • Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
  • Subject is currently not bedridden.
  • Subject in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
  • Subject must be comfortable with speaking, reading and understanding questions and providing responses in an available translated language for the PROs in the protocol.
  • The devices specified in this protocol were implanted.

Exclusion Criteria:

  • Subject is a woman who is pregnant or lactating.
  • Contralateral knee has already been enrolled in this study.
  • Subject had a contralateral amputation.
  • Previous partial knee replacement (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
  • Subject is currently experiencing radicular pain from the spine.
  • Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
  • Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
  • Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
  • Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
  • Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
  • Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, etc.).
  • Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol.
  • Subject has a medical condition with less than 5 years of life expectancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754363

Contacts
Contact: Verdonna Huey, M.S., B.S.N, CCRP +1 574-372-5932 vhuey@its.jnj.com

  Show 23 Study Locations
Sponsors and Collaborators
DePuy International
Investigators
Study Director: Verdonna Huey, M.S., B.S.N, CCRP DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT01754363     History of Changes
Other Study ID Numbers: 10008
Study First Received: December 18, 2012
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy International:
Osteoarthritis

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 26, 2014